> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Merck sBLA for Keytruda in Lung Cancer
- URL: https://www.fdaweb.com/merck-sbla-for-keytruda-in-lung-cancer/
- Published: 2018-09-12T12:00:00.000Z
- Updated: 2026-09-15T00:31:22.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5142340

FDA has accepted for priority review a supplemental BLA for Keytruda, an anti-PD-1 therapy, as monotherapy for first-line treatment of locally advanced or metastatic nonsquamous or squamous non-small cell lung cancer (NSCLC) in patients whose tumors express PD-L1 without *EGFR* or *ALK* genomic tumor aberrations. The submission is based on data from the pivotal Phase 3 KEYNOTE-042 trial, one of five Phase 3 clinical trials with Keytruda in NSCLC to demonstrate a significant improvement in overall survival. Data from the trial were presented earlier this year at the 2018 American Society of Clinical Oncology annual meeting. The agency has set a user fee review action target of 1/11/2019.